Because SPRAVATO® is a Schedule III controlled substance, your treatment center will require appropriate storage of SPRAVATO®.1
Staff protocols will need to be established for handling and disposal of SPRAVATO® as well, in accordance with federal and state laws and regulations.1
1. SPRAVATO® Prescribing Information. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.
With dosing and monitoring requirements for SPRAVATO®, it is important for treatment centers to consider appropriate use of staff and space
A treatment space can be a room or designated area within your practice. Considerations for creating a treatment space for SPRAVATO® include a:
Chair in which a patient can comfortably sit for at least 2 hours during monitoring
Blood pressure cuff
Trained healthcare provider to monitor the patient
Examples of how a SPRAVATO® treatment space may be set up
Multiple treatment chairs per space
Single treatment chair per space
For illustrative purposes only. Not intended to represent a promise, guarantee, or legal advice by Janssen Pharmaceuticals, Inc., about practice efficiencies.
Learn more about the SPRAVATO® REMS program requirements.
Consider dosing and administration requirements for SPRAVATO® so you can manage your patients accordingly
Induction and maintenance dosing for adult patients with treatment-resistant depression (TRD)
Designed to address your patients’ long-term needs, with frequency and dosing strength that are flexible and based on clinical judgment
*Evidence of therapeutic benefit should be evaluated at the end of the induction phase to determine need for continued treatment.
†Dosing frequency should be individualized to the lowest frequency required to maintain remission/response.
‡As determined by the prescribing physician.
Four weeks of consistent dosing to serve your patients’ needs
MSDI=depressive symptoms in adults with MDD with acute suicidal ideation or behavior.
After 4 weeks of treatment with SPRAVATO®, evidence of therapeutic benefit should be evaluated to determine need for continued treatment. Treatment beyond 4 weeks has not been systematically evaluated.
§Dosing may be reduced to 56 mg twice per week based on tolerability.
Before administration
Patients will need to know ahead of time that1:
Administration
Monitoring and discharge
Read the full Prescribing Information and Dosing and Administration Guide for administration instructions and post-administration observation requirements.
1. SPRAVATO® Prescribing Information. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.
Patients must be informed that SPRAVATO® treatment requires a series of frequent appointments.
Example of SPRAVATO dosing frequency over time1
TRD=treatment-resistant depression in adults.
*For weeks 9 and after, administer SPRAVATO® every 2 weeks or once weekly (56 mg or 84 mg). Dosing frequency should be individualized to the least frequent dosing to maintain remission/response.
After 4 weeks of treatment with SPRAVATO®, evidence of therapeutic benefit should be evaluated to determine need for continued treatment.
For illustrative purposes only and not intended to represent a promise, guarantee, or legal advice by Janssen Pharmaceuticals, Inc., about practice efficiencies.
MDSI=depressive symptoms in adults with MDD with acute suicidal ideation of behavior.
After 4 weeks of treatment with SPRAVATO®, evidence of therapeutic benefit should be evaluated to determine need for continued treatment. Treatment beyond 4 weeks has not been systematically evaluated.
For illustrative purposes only and not intended to represent a promise, guarantee, or legal advice by Janssen Pharmaceuticals, Inc., about practice efficiencies.
A staggered SPRAVATO® treatment schedule can allow 1 clinical staff member or physician to manage multiple patients simultaneously1*
Example of staff and chair use when offering SPRAVATO®.
*These times may vary by patient and by whether this is the patient’s first treatment session or a subsequent treatment session. Additional monitoring beyond 2 hours and discharge are up to clinician judgment.
†Assess blood pressure prior to administration and wait 5 minutes after each device to allow medication to fully absorb. Patient may use up to 3 devices, which may require up to 15 minutes.
‡Blood pressure is assessed prior to and approximately 40 minutes after dosing with SPRAVATO®, and subsequently as clinically warranted until values decline.
§Patients must be monitored by a healthcare provider for at least 2 hours at each treatment session, followed by an assessment to determine when the patient is considered clinically stable and ready to leave the healthcare setting. Instruct patients not to engage in potentially hazardous activities requiring complete mental alertness and motor coordination, such as driving a motor vehicle or operating machinery, until the next day following a restful sleep.
For illustrative purposes only and not intended to represent a promise, guarantee, or legal advice by Janssen Pharmaceuticals, Inc., about practice efficiencies.
1. SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.
Ask your Janssen representative about the SPRAVATO® Operational Considerations Tool. The tool can help your practice understand resource capacity to help plan for SPRAVATO® treatment based on your number of patients, available treatment chairs, and time required for treatment and monitoring.
Packaging
SPRAVATO® is available in the following presentations:
Storage
1. SPRAVATO® [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals, Inc. July 2020.
Once the SPRAVATO® device has been used by the patient, it should be disposed of as medical waste according to local, state, and federal regulations for controlled substances.
After 14 days, unused named-patient products must be appropriately disposed of according to state and federal regulations and may not be returned to the general inventory of the healthcare setting or pharmacy.
WHAT IS IT?
WHEN TO USE IT?
HOW TO USE IT?
WHAT CAN YOU EXPECT?
If the patient received 1 spray and then either the patient or the healthcare provider decided not to continue with treatment, the partially used product must be disposed of.
Contact the SPRAVATO® Disposal Program to dispose of unused or partially used devices if your healthcare setting is not equipped to do so. Simply call 888-912-7348.
If the product is past the expiration date printed on the box and blister pack, coordinate with the pharmacy that sent you the expired product to exchange it for new product.
If you purchased the product from a distributor or wholesaler, you can learn about the returns process and eligibility criteria by calling INMAR® at 800-967-5952, or click here to review Janssen’s Returns Policy.
If the device has prematurely expelled medication—or won’t expel medication—then a healthcare provider should call Janssen Medical Information at 800-JANSSEN to report a product quality complaint.
The Medical Information team will assist in taking the complaint submission. Your staff must then determine how to obtain more product to prevent the patient from missing doses (if possible) and follow the process for returning the device.
